
1001 - 5000 employés
💊 Pharmaceutique
🏥 Santé
🧬 Biotechnologie
Pharmaceuticals • Healthcare • Biotechnology
Les Entreprises Pharmaceutiques Otsuka (États-Unis) sont un acteur de premier plan dans l'industrie de la fabrication pharmaceutique, dédiées à la création de produits innovants pour améliorer la santé mondiale. La société se compose de deux entités principales : Otsuka America Pharmaceutical, Inc. (OAPI), qui se concentre sur la commercialisation des produits découverts par Otsuka et sous licence en Amérique du Nord, et Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), spécialisée dans le développement clinique et l'enregistrement mondial de solutions de santé innovantes, particulièrement dans le domaine des neurosciences.
🕒 il y a 2 mois
🇺🇸 États-Unis – Télétravail
💵 $249 973 - $388 125 / an
⏰ Temps Plein
🟠 Senior
👔 Directeur
👻 Score fantôme 15%
🗣️🇺🇸🇬🇧 Anglais requis
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1001 - 5000 employés
💊 Pharmaceutique
🏥 Santé
🧬 Biotechnologie
Pharmaceuticals • Healthcare • Biotechnology
Les Entreprises Pharmaceutiques Otsuka (États-Unis) sont un acteur de premier plan dans l'industrie de la fabrication pharmaceutique, dédiées à la création de produits innovants pour améliorer la santé mondiale. La société se compose de deux entités principales : Otsuka America Pharmaceutical, Inc. (OAPI), qui se concentre sur la commercialisation des produits découverts par Otsuka et sous licence en Amérique du Nord, et Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), spécialisée dans le développement clinique et l'enregistrement mondial de solutions de santé innovantes, particulièrement dans le domaine des neurosciences.
• Lead the clinical development strategy and execution for assigned programs after proof of concept through late-stage trials and regulatory submissions • Provide medical and scientific leadership to cross-functional study teams • Serve as the medical lead and subject matter expert for assigned indications • Partner with cross-functional team to ensure trials are conducted in compliance with GCP and regulatory requirements • Lead and contribute to development of clinical sections of regulatory documents, including INDs, IBs, clinical study reports, and NDAs/BLAs • Collaborate with regulatory affairs on interactions with global health authorities • Develop clinical documents including medical monitoring plans and asset development plans • Mentor and provide leadership to junior team members within the organization • Support business development activities through medical due diligence and evaluation of external opportunities
• A clinician (M.D., or D.O.) preferably with an immunology, rheumatology, or dermatology background including management experience (direct or indirect) • Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus • Minimum of five years of clinical research experience, post academia • Thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing) • Advanced understanding of drug development principles and clinical trial implementation and management • Complete understanding of the global regulatory requirements • Working knowledge of marketing and commercialization • Strong communication and presentation skills • Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
• Comprehensive medical, dental, vision, prescription drug coverage • Company provided basic life, accidental death & dismemberment insurance • Short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • Generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs • Other company provided benefits
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